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WO2021088145A1 - Endoprothèse appropriée pour une implantation dans une cavité anévrismale d'une maladie de dilatation aortique - Google Patents

Endoprothèse appropriée pour une implantation dans une cavité anévrismale d'une maladie de dilatation aortique Download PDF

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Publication number
WO2021088145A1
WO2021088145A1 PCT/CN2019/120320 CN2019120320W WO2021088145A1 WO 2021088145 A1 WO2021088145 A1 WO 2021088145A1 CN 2019120320 W CN2019120320 W CN 2019120320W WO 2021088145 A1 WO2021088145 A1 WO 2021088145A1
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WO
WIPO (PCT)
Prior art keywords
implanting
main body
tumor cavity
graft
disease according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2019/120320
Other languages
English (en)
Chinese (zh)
Inventor
冯睿
朱铁桥
景在平
冯家烜
曾照祥
赵玉玺
吴明炜
鲍贤豪
艾克白尔江艾尼瓦尔
李涛
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fuman Medical Technology
Yingjia Medical Materials
Original Assignee
Fuman Medical Technology
Yingjia Medical Materials
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201911087389.7A external-priority patent/CN112773444A/zh
Priority claimed from CN201921920290.6U external-priority patent/CN211749821U/zh
Application filed by Fuman Medical Technology, Yingjia Medical Materials filed Critical Fuman Medical Technology
Publication of WO2021088145A1 publication Critical patent/WO2021088145A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts

Definitions

  • the invention relates to the field of medical devices, in particular to a graft suitable for implanting into the tumor cavity of aortic dilatation disease.
  • Aortic dilatation disease is a disease with dangerous onset, rapid progress, and high mortality.
  • This type of disease is mainly divided into true aortic aneurysm, aortic dissection and pseudo aortic aneurysm.
  • the current treatment for this type of disease is mainly divided into Surgical treatment and catheter interventional treatment.
  • Surgical treatment is mainly artificial blood vessel replacement
  • catheter intervention is mainly percutaneous stent grafting (ie endoluminal isolation).
  • Artificial blood vessel replacement is an open operation. Due to its large trauma, long operation time, high mortality and complications, it is not suitable for elderly and weak patients.
  • the use of covered stents for endovascular exclusion for aortic dilatation disease has the advantages of less surgical trauma, faster postoperative recovery, and shorter hospital stay.
  • the tumor cavity cannot be completely thrombosis, in order to achieve the purpose of vascular remodeling. Packing of the tumor cavity can not only promote the complete thrombosis of the tumor cavity, but also treat the formation of endoleak after endocavity isolation.
  • Embolic agents are usually divided into solid embolic agents and liquid embolic agents.
  • PVA polyvinyl alcohol
  • coils are commonly used as fixed embolic agents.
  • existing embolic materials have some shortcomings.
  • the coils are mainly made of stainless steel, platinum and their alloys, and do not have a shape memory function. After they are placed in the tumor cavity, they cannot be filled according to a predetermined shape, especially when filling large tumors. In the cavity, insufficient packing of the tumor cavity will occur.
  • the existing liquid embolization materials such as ONXY glue can achieve irregular embolization of the tumor cavity, but it is easy to move with the blood, and when the volume of the aortic aneurysm cavity or false cavity is too large, the embolization is not complete, and the operation cost is difficult. Etc. are larger.
  • the present invention provides a graft suitable for implanting into the aneurysm cavity of aortic dilatation disease, so that when it is filled in the aortic aneurysm cavity or aortic dissection, it has expansion and contraction properties.
  • the aortic aneurysm cavity can be fully packed, and the cure rate of the graft can be improved.
  • the embodiments of the present invention provide a graft suitable for implanting into the tumor cavity of aortic dilatation disease, which includes: a skeleton having a main body and a branch stent connected to the periphery of the main body; and a coating Body, covered on the outer periphery of the skeleton; wherein the covering body is made of a material that expands or contracts according to changes in the implantation environment, and the branch stent can be expanded or contracted with the expansion or contraction of the covering body Expand or contract relative to the main body.
  • the material of the framework is a material with a certain supporting force, such as Nitinol, or a polymer material, which can generate a certain supporting force from the inside of the graft.
  • the covering body can expand or contract according to the change of the implantation environment.
  • the covering body absorbs water from the implantation environment, it expands, and it expands to reach the embolism cavity or pseudosurgery.
  • the purpose of the cavity may expand according to the body temperature of the implantation environment, that is, may be made of a thermally expandable material.
  • At least one layer of the branch bracket is formed on the outer circumference of the main body.
  • the branch stent may be provided with one layer, two layers or multiple layers, and the number of layers of the branch stent can be adjusted according to the length of the main body and the support strength of the branch stent to meet the requirements of different implantation environments.
  • the branch brackets of each layer are evenly distributed along the circumference of the main body. According to the embodiment of the present invention, evenly distributing the branch stents of each layer along the circumference of the main body can ensure that when the branch stents are implanted in the aneurysm cavity, the force of the entire graft is uniform, and the graft is ensured in the aneurysm cavity. keep it steady.
  • each layer is provided with 2 to 18 branch brackets. For example, 2, 6, 10, 14, or 18.
  • the number of branch stents can be adjusted according to the actual use environment to ensure that the branch stents have a certain supporting effect on the entire graft, and at the same time prevent the branch stents from being too strong, which is not conducive to implantation. And other issues.
  • the skeleton includes at least three layers of the branch support, and the interval between two adjacent layers is the same.
  • the interval between two adjacent layers is the same to ensure that the skeleton receives the force of the branch stents evenly, and prevents There is a risk that the covering body deforms and compresses the main body.
  • the interval is 2 mm to 10 mm.
  • the interval can be adjusted according to the implantation environment of the graft, so as to meet the optimal setting.
  • the outer diameter of the skeleton that is, the diameter of the circumscribed circle of a layer of branch stents is 10 mm to 40 mm.
  • the outer diameter of the skeleton is set to 10 mm, 20 mm, 30 mm, or 40 mm.
  • grafts with different skeleton outer diameters can be selected according to the position of the implanted aortic aneurysm cavity, so that the graft can fully fill the aneurysm cavity after being implanted in the aortic aneurysm cavity.
  • the angle between the branch stent and the main body is in the range of 10° To 90°. For example, 10°, 50°, or 90°.
  • grafts with different angles in a fully expanded state can be selected according to actual needs.
  • the covering body Before the graft is implanted into the tumor cavity, the covering body is compressed by external force to make the branch stent and The included angle between the main body is close to 0°.
  • the branch stent After the graft is implanted into the tumor cavity, the branch stent is deployed relative to the main body, so that the included angle is kept at less than or equal to the maximum angle when it is fully deployed between. In this way, on the one hand, it is ensured that the graft can fully fill the tumor cavity by expansion after being implanted in the tumor cavity, and on the other hand, it is ensured that the branch stent has a certain supporting effect on the graft.
  • the branch stent is configured in a cylindrical shape with a diameter of 1 mm to 2 mm.
  • the skeleton contains a developing material or is provided with a developing mark made of a developing material.
  • a developing material or a developing mark is provided in the skeleton. After the graft is implanted into the tumor cavity or dissection, the tumor cavity or dissection can be located in real time through visualization to improve implantation. Accuracy.
  • a procoagulant drug is provided in the coating body.
  • the provision of a procoagulant drug in the coating body can promote the thrombosis of the tumor cavity or dissection and improve the therapeutic effect.
  • the branch bracket and the main body are integrally formed.
  • the covering body is a sponge.
  • the sponge adopts a water-absorbing swelling material. After the graft is implanted in the body, the sponge absorbs water and expands to achieve the purpose of embolizing the tumor cavity or false cavity. After the sponge is foamed, the density of the sponge is reduced by reducing the density of the sponge. And compression to achieve high expansion performance.
  • the material includes: polyvinyl alcohol (PVA), polyvinyl fluoride (PVF), or polyglycolide (PGLA).
  • PVA polyvinyl alcohol
  • PVF polyvinyl fluoride
  • PGLA polyglycolide
  • PVA particles are expandable and compressible. They are made of polyvinyl alcohol foam and formaldehyde through cross-linking, drying, crushing, sieving and other processes. They are non-water-soluble and the commonly used size is 100 ⁇ 1000 ⁇ m, it can swell in contact with aqueous liquid, and the volume swells about 20%.
  • the implementation of the present invention has the following beneficial effects:
  • a covering body is arranged outside the skeleton, and the covering body expands or contracts according to the change of the implantation environment, for example, expands when encountering an aqueous liquid or expands according to body temperature, so that the graft can better treat the tumor
  • the cavity or interlayer is fully filled to improve the treatment effect. With the developed skeleton in the middle, the tumor cavity or dissection can be better positioned.
  • the covering body is used to cover the main body and branch brackets of the skeleton, which can effectively avoid the embolic material from squeezing the whole skeleton and the tumor cavity wall, and reduce the risk of tumor cavity rupture.
  • FIG. 1 is a three-dimensional schematic diagram of a graft involved in an exemplary embodiment of the present invention, which uses a dotted line to show the internal skeleton;
  • Fig. 2 is a schematic top view of the graft shown in Fig. 1, which shows the internal skeleton with dashed lines;
  • Fig. 3 is a cross-sectional view of the graft shown in Fig. 1 along the line A-A of Fig. 2.
  • Figures 1 to 3 show schematic structures of grafts according to exemplary embodiments of the present invention.
  • the graft may include a skeleton 1 and a covering body 2 covering the outer circumference of the skeleton 1, wherein the skeleton 1 may include a main body 11 and a branch stent connected to the outer circumference of the main body 11. 12.
  • the main body 11 and the branch stent 12 may be integrally formed of a nickel-titanium alloy into the skeleton 1.
  • the main body 11 of the skeleton 1 is formed into a cylindrical shape, and a multi-layer branch stent 12 is integrally formed on the outer peripheral side of the main body 11.
  • the main body 11 and the branch bracket 12 have a certain supporting effect on the covering body 2, and the branch bracket 12 can be expanded or contracted relative to the main body 11.
  • the branch brackets 12 are arranged in 4 layers, each layer is provided with 2-18 branch brackets, for example 8, and the branch brackets on each layer are evenly distributed along the circumference of the main body 11 to ensure The branch brackets 12 of each layer are equally spaced on the circumference. It can be seen from FIG. 2 that the extension lines of all the branch brackets 12 of each layer intersect on the central axis of the main body 11.
  • the interval between two adjacent layers of the 4-layer branch bracket 12 is the same, and the interval is set between 2-10 mm, for example, 6 mm.
  • the number of layers of the branch stents may be 1 layer, 2 layers, or 5 layers, 6 layers or more, and each layer of branch stents may be unevenly distributed along the circumference.
  • the interval between two adjacent layers may be unequal.
  • the outer diameter of the skeleton 1, that is, the diameter of the circle enclosed by the outermost end of the branch bracket 12 is 10 mm to 40 mm, for example, 25 mm.
  • the inside of the skeleton 1 contains a visualization material, such as barium sulfate or a visualization strip.
  • the skeleton may be made of a rigid sponge or the like with a developing function, or a developing mark may be provided on the skeleton.
  • the upper and lower ends of the covering body 2 are provided with arc-curved chamfers at the joints between the upper and lower ends of the covering body 2 to ensure that the covering body 2 will not damage the lesion position during implantation.
  • the outer diameter of the covering body 2 is larger than the outer diameter of the skeleton 1, so that the skeleton 1 and the lesion position have a certain distance, and at the same time, the covering body 2 has a certain buffering effect.
  • the covering body 2 is made of sponge, and the sponge covering body covers the outside of the skeleton 1 to form a soft layer. When it contacts the tumor cavity wall, it can reduce the compression of the tumor cavity and reduce the rupture of the tumor cavity. risks of.
  • the sponge coating is made of water-absorbing or thermally expanding materials, such as PVA, PVF or PGLA.
  • PVA water-absorbing or thermally expanding materials
  • PGLA thermally expanding materials
  • the sponge covering body When the sponge covering body is implanted in the human body, it absorbs water or absorbs human body heat and expands, so that the covering body 2 fully fills the tumor cavity or interlayer.
  • a procoagulant drug such as a coagulation factor, is dispersed in the sponge coating body to promote thrombosis of the tumor cavity.
  • the branch bracket 12 and the central axis of the main body 11 form a certain included angle ⁇ , as shown in FIG. 3, and when the branch bracket 12 is fully deployed relative to the main body 11, the included angle ⁇
  • the range of is between 10° and 90°, and grafts with different included angles can be selected according to actual needs. For example, a graft with a maximum of 45° can be selected.
  • the covering body 2 is compressed by external force.
  • the branch stent 12 shrinks relative to the main body 11 as the covering body 2 shrinks, and the angle ⁇ formed by the branch stent 12 and the central axis of the main body 11 decreases.
  • the branch stent 12 is gathered along the axial direction, that is, the angle between the branch and the main body is close to 0°, the implantation volume of the graft is reduced, and the operation is convenient for the surgeon.
  • the graft is implanted in the body, the graft is released, and the covering body 2 expands by absorbing water.
  • the branch stent 12 expands relative to the main body 11 as the covering body 2 expands.
  • the branch stent 12 and The included angle ⁇ formed by the central axis of the main body 11 increases, and ⁇ 45°.
  • the branch stent 12 supports the covering body 2 so that the covering body 2 can fully fill the tumor cavity or dissection.
  • the implantation method of the graft involved in the present invention is as follows:
  • the implantation position of the graft is determined according to the development of the skeleton 1 during the radiography. After reaching the designated position, the graft is supported by the introducer sheath core, and the delivery sheath is withdrawn to release the graft and transport During the process, the skeleton 1 of the graft plays a supporting role in the tumor cavity to avoid distortion of the graft itself. After the graft is released, the outer covering body 2 gradually expands after absorbing the water or heat in the blood, thereby reducing The tumor cavity is completely filled, which better promotes the thrombosis of the tumor cavity.

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une endoprothèse appropriée pour une implantation dans une cavité anévrismale d'une maladie de dilatation aortique, se rapportant au domaine des instruments médicaux. L'endoprothèse comprend : un cadre (1) comprenant un corps principal (11) et un stent ramifié (12) relié à la périphérie du corps principal (11) ; et un corps de recouvrement (2) qui recouvre la périphérie du cadre (1). Le corps de recouvrement (2) est constitué d'un matériau qui se dilate ou se contracte en fonction du changement d'environnement d'implantation, et le stent ramifié (12) peut se dilater ou se contracter par rapport au corps principal (11) conjointement avec l'expansion ou la contraction du corps de recouvrement (2). L'endoprothèse est remplie dans la cavité anévrismale aortique ou la dissection aortique pour emboliser la cavité anévrismale, a une performance d'auto-expansion pour un remplissage suffisant de la cavité anévrismale, et a une surface souple de façon à avoir un effet protecteur sur la cavité anévrismale et le stent de corps principal.
PCT/CN2019/120320 2019-11-08 2019-11-22 Endoprothèse appropriée pour une implantation dans une cavité anévrismale d'une maladie de dilatation aortique Ceased WO2021088145A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201911087389.7A CN112773444A (zh) 2019-11-08 2019-11-08 适于植入主动脉扩张性疾病瘤腔的移植物
CN201911087389.7 2019-11-08
CN201921920290.6 2019-11-08
CN201921920290.6U CN211749821U (zh) 2019-11-08 2019-11-08 适于植入主动脉扩张性疾病瘤腔的移植物

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WO2021088145A1 true WO2021088145A1 (fr) 2021-05-14

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PCT/CN2019/120320 Ceased WO2021088145A1 (fr) 2019-11-08 2019-11-22 Endoprothèse appropriée pour une implantation dans une cavité anévrismale d'une maladie de dilatation aortique

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1403170A (zh) * 2002-09-28 2003-03-19 维科医疗器械(苏州)有限公司 防止内漏的主动脉覆膜支架
WO2004045393A2 (fr) * 2002-11-20 2004-06-03 Fogarty, Thomas, J. Dispositifs et methodes de traitement d'anevrismes vasculaires
US20050090861A1 (en) * 2003-10-27 2005-04-28 Scimed Life Systems, Inc. Vaso-occlusive devices with in-situ stiffening elements
US20120226304A1 (en) * 2011-03-02 2012-09-06 Ryan Chelsey Elizabeth Embolization coil
CN103717156A (zh) * 2011-08-12 2014-04-09 W.L.戈尔及同仁股份有限公司 用于去除治疗部位处的动脉粥样硬化斑块或血栓的系统
CN104873304A (zh) * 2014-12-19 2015-09-02 中国人民解放军第二军医大学 附优化周向张力海绵结构的防i型内漏支架移植物系统
CN104887348A (zh) * 2014-12-19 2015-09-09 中国人民解放军第二军医大学 附海绵结构的防i型内漏支架移植物系统
CN107569300A (zh) * 2017-09-25 2018-01-12 上海长海医院 一种治疗主动脉夹层假腔的腔内修复移植物

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1403170A (zh) * 2002-09-28 2003-03-19 维科医疗器械(苏州)有限公司 防止内漏的主动脉覆膜支架
WO2004045393A2 (fr) * 2002-11-20 2004-06-03 Fogarty, Thomas, J. Dispositifs et methodes de traitement d'anevrismes vasculaires
US20050090861A1 (en) * 2003-10-27 2005-04-28 Scimed Life Systems, Inc. Vaso-occlusive devices with in-situ stiffening elements
US20120226304A1 (en) * 2011-03-02 2012-09-06 Ryan Chelsey Elizabeth Embolization coil
CN103717156A (zh) * 2011-08-12 2014-04-09 W.L.戈尔及同仁股份有限公司 用于去除治疗部位处的动脉粥样硬化斑块或血栓的系统
CN104873304A (zh) * 2014-12-19 2015-09-02 中国人民解放军第二军医大学 附优化周向张力海绵结构的防i型内漏支架移植物系统
CN104887348A (zh) * 2014-12-19 2015-09-09 中国人民解放军第二军医大学 附海绵结构的防i型内漏支架移植物系统
CN107569300A (zh) * 2017-09-25 2018-01-12 上海长海医院 一种治疗主动脉夹层假腔的腔内修复移植物

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